Tadalafil Tablets (Pulmonary Hypertension)

What is this medication?

TADALAFIL (tah DA la fil) treats pulmonary arterial hypertension (PAH), a condition that causes high blood pressure in the lungs. It works by relaxing your blood vessels and lowering the blood pressure in your lungs, which makes it easier for your heart to pump blood to the rest of your body. It can also help you breathe easier and be more active.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Adcirca, ALYQ, Cialis

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Abnormal penis shape or Peyronie disease
• Bleeding disorder
• Blood diseases, such as sickle cell anemia or leukemia
• Eye disease, such as retinitis pigmentosa
• Have had a heart attack
• Have had a painful and prolonged erection
• Have had a stroke
• Heart disease, such as angina, heart failure, irregular heartbeat or rhythm
• High or low blood pressure
• Kidney disease
• Liver disease
• Pulmonary vascular occlusive disease (PVOD)
• Stomach ulcers, other stomach or intestine problems
• An unusual or allergic reaction to tadalafil, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. You can take this medication with or without food. Take your medication at regular intervals. Take both tablets at the same time, one after the other. Do not split your dose throughout the day. Do not take it more often than directed. Do not stop taking except on your care team's advice.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Medications for erectile dysfunction, such as avanafil, sildenafil, vardenafil
• Nitrates, such as amyl nitrite, isosorbide dinitrate, isosorbide mononitrate, nitroglycerin
• Other tadalafil products (Cialis)
• Riociguat

This medication may also interact with the following:

• Certain medications for high blood pressure
• Certain medications for HIV or AIDS
• Certain medications used for fungal infections, such as fluconazole, itraconazole, ketoconazole, voriconazole
• Certain medications used for seizures, such as carbamazepine, phenytoin, phenobarbital
• Grapefruit juice
• Macrolide antibiotics, such as clarithromycin or erythromycin
• Medications for prostate conditions
• Rifabutin, rifampin, or rifapentine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

Stop and call your care team right away if you have symptoms such as nausea, dizziness, or chest pain during sex.

Contact your care team right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects. Do not have more than 4 alcohol-containing drinks in a short period of time while taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Hearing loss or ringing in ears
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Prolonged or painful erection
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Sudden vision loss in one or both eyes

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Back pain
• Facial flushing or redness
• Headache
• Muscle pain
• Runny or stuffy nose
• Upset stomach

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.